Last Updated: September 24, 2026

Details for New Drug Application (NDA): 075560

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NDA 075560 describes CIMETIDINE HYDROCHLORIDE, which is a drug marketed by Hospira, Luitpold, Ph Health, Teva Parenteral, Ani Pharms, Chartwell Molecular, Cycle, G And W Labs Inc, Pai Holdings Pharm, Pharm Assoc, and Pharmobedient Cnsltg, and is included in twenty-one NDAs. It is available from three suppliers. Additional details are available on the CIMETIDINE HYDROCHLORIDE profile page.

The generic ingredient in CIMETIDINE HYDROCHLORIDE is cimetidine hydrochloride. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the cimetidine hydrochloride profile page.

Summary for 075560

Tradename:	CIMETIDINE HYDROCHLORIDE
Applicant:	Pharm Assoc
Ingredient:	cimetidine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	EQ 300MG BASE/5ML
Approval Date:	Mar 15, 2000	TE:		RLD:	No

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